Anti-Human Globulin Anti-IgG - Green

Basic Information

• Brand Name: Anti-Human Globulin Anti-IgG - Green
• Primary DI: 23661562105476
• Version / Model: 210547
• Catalog Number: 210547
• Company Name: DIAGAST
• Labeler DUNS: 381527001
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2018-05-01
• Public Version: 3
• Public Version Date: 2021-05-24
• Public Version Status: Update
• Public Device Record Key: acc1817d-be66-4089-b557-10a7009bce0d

Device Description

Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
46948	Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody	One or multiple immunoglobulins capable of binding to human antibodies from immunoglobulin class G (IgG) that are fixed to red blood cell antigens. This immunoglobulin, known as monospecific immunoglobulin G antihuman globulin (IgG AHG) is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human IgG, using an agglutination or solid-phase red blood cell adherence method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	23661562105476	GS1
Unit of Use	13661562105479	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius